82% des principales entreprises pharmaceutiques utilisent la RFID pour répondre aux normes GMP de la FDA et de l’UE. Pour les fournisseurs de services système, this represents a high-value opportunity to provide mission-critical automation solutions. Here is an actionable guide:
RFID Applications in Pharmaceutical Automation
1.Drug Substance Tracking
- Application: RFID tags on raw material containers track API (active pharmaceutical ingredients) batches to ensure compliance with FDA DSCSA regulations.
2.Aseptic Manufacturing Control
- Isolator Monitoring: RFID-tagged vials in the filling line verify sterilization parameters (time/temperature) to meet ISO 13408 Normes.
- Tool Tracking: Pfizer uses RFID to manage freeze-drying equipment lifecycles in a Class A environment.
3.Packaging and Serialization
- UDI Compliance: RFID tags encode GTIN, Numéro de lot, and expiration date for automated GS1 compliance in 120+ markets.
- Tamper Evidence: Encrypted labels on vaccine packaging (piloted by Moderna) prevent counterfeiting in cold chain logistics.
4.Clinical Trial Management
- Sample Integrity: RFID cryogenic tags track trial medications at -80°C, maintaining FDA 21 Pièce CFR 312 chain of custody.
- Patient Adherence: Smart blister packaging with RFID records dosing times for real-time trial data collection.
5.Waste and Sustainability
- Hazardous Waste Tracking: RFID tags on cytotoxic waste containers automatically generate EPA RCRA compliance reports.
- Reusable Asset Management: RFID stainless steel totes at Roche facility achieve 99% recycling rate.
Non-automated scenarios and RFID opportunities
| Processus manuel | RFID Solution | Impact |
|---|---|---|
| Paper-based batch records | RFID + eDHR (Electronic Device History Record) | Éliminer 95% documentation errors |
| Visual inspection of labels | RFID-enabled vision systems | Reduce mislabeling by 88% |
| Manual sample logging | RFID-tagged cryoboxes | Cut lab processing time by 50% |
Pharma RFID system components
1.Matériel
- Tags: Autoclave-safe, cryogenic variants
- Lecteurs: Cleanroom-compatible (ISO 14644) fixed/handheld readers
- Antennes: Near-field for vial scanning, wide beam for trays
2.Logiciel
- Middleware: Intégration avec MES (par exemple. Werum PAS-X) and QMS (Veeva)
- Analytics: Real-time dashboards for OEE, deviations, and audit trails
3.Intégrations
- ERP connectivity (SAP S/4HANA, Oracle)
- DSCSA-compliant blockchain platforms
Recommended RFID tags for the pharmaceutical industry
| Application | Balise recommandée | Caractéristiques principales |
|---|---|---|
| Cryogenic Storage | Étiquette RFID UHF ultra petite | -196°C stable, 2×5.8mm, ISO 10993 conforme |
| Drug Packaging | Inlays RFID UHF | Encrypted, embeddable in foil blisters |
| Reusable Containers | Ceramic RFID Tags | Indice IP69K, withstands CIP/SIP cleaning |
Compliance: Fda 21 Pièce CFR 11, EU Annex 11, ISO 14644
Nous offrons:
RFID tracking in sterile manufacturing
RFID inventory management for pharmaceutical production
UHF RFID tags for medical packaging
RFID solutions for pharmaceutical serialization
Why work with a pharmaceutical specialty supplier?
Pharmaceutical Customer Needs:
✅ Regulatory Mastery: Expertise in FDA/EU GMP Computerized System Validation
✅ Contamination Control: Hardware Design for USP <800> Compliance
✅ Global Serialization: Solutions to support DSCSA, FMD, and China DMC
[Contactez-nous] to design an RFID solution that delivers:
- 100% DSCSA compliance
- 60% faster batch release
- Real-time deviation alerts
